Comparison of the effect of biofeedback and repetitive transcranial magnetic stimulation on pelvic floor muscles function in women with urinary incontinence
Comparing the effect of biofeedback and repeated transcranial magnetic stimulation on pelvic floor muscle function in urinary incontinence women
Design
A randomized clinical trial with a control group and two groups with different therapeutic interventions, and parallel design, double-blind, will be conducted on 33 patients. Block balanced randomization method is used for randomization.
Settings and conduct
The study will be conducted at Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. Urinary incontinence patients fall into one of three groups by accident. The evaluator and the patients are not aware of the allocation method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women 35 to 70 years old with urinary incontinence; Urine loss of more than 1 gram per hour and confirmed by a one-hour test pad; Associated sexual impotence.
Exclusion criteria:
History of cesarean section; Pelvic organ prolapse; Active or frequent urinary tract infections; The presence of a copper IUD in the uterus; Pregnancy or childbirth less than 6 months; History of surgery in the abdomen and pelvis; History of constipation;
Intervention groups
RTMS intervention group receives 20 minutes of inhibitory pusles applied on supplementory area of cortex.
The other group intervention includes a combination of 15 minutes of electromyographic biofeedback with vaginal probe and progressive exercises of pelvic floor muscles.
The control group only receives routine pelvic floor physiotherapy exercises including Kegel exercises.
Treatment sessions will be held 3 times a week for a total period of 3 weeks.
Main outcome variables
Average work of the pelvic floor muscles; Average relaxation of pelvic floor muscles; Minimum contraction of pelvic floor muscles; Maximum contraction or peak of pelvic floor muscles; ICIQ-VS questionnaire score; Displacement of the bladder surface
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230305057630N1
Registration date:2023-05-09, 1402/02/19
Registration timing:prospective
Last update:2023-05-09, 1402/02/19
Update count:0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
Maryam Miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5526 6112
Email address
maryammiritorbaghan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of biofeedback and repetitive transcranial magnetic stimulation on pelvic floor muscles function in women with urinary incontinence
Public title
Comparing the effects of biofeedback and brain stimulation treatments on pelvic floor muscle function in women with urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 35 to 70 years with urinary incontinence as the main clinical complaint, without urgent symptoms
Urine loss of more than 1 gram per hour should be confirmed by a one-hour test pad
The simultaneous presence of sexual disorders and impotence with urinary incontinence
Absence of chronic degenerative diseases that affect muscle and nerve tissues
Absence of any degree of pelvic organ prolapse (POP)
Absence of active or recurrent urinary tract infections (UTIs)
Absence of vulvovaginitis
Absence of atrophic vaginitis
Absence of copper IUD in the uterus
Absence of pregnancy or childbirth less than 6 months
Not suffering from diabetes, neurological disease, mental illness, and debilitating chronic diseases such as kidney failure and heart pacemakers.
Absence of taking drugs that affect urination
No history of surgical or drug treatment of SUI
No history of abdominal and inguinal hernia
No history of any surgery in the abdomen and pelvis (due to adhesions in the area and impact on the bladder)
Absence of constipation
No history of seizures
Exclusion criteria:
Having a urinary infection
History of cesarean section
Unwillingness to cooperate
Suffering from chronic degenerative diseases that affect muscle and nerve tissues
Presence of any degree of pelvic organ prolapse (POP)
Presence of active or recurrent urinary tract infections (UTIs)
Presence of vulvovaginitis
Presence of atrophic vaginitis
Presence of a copper IUD in the uterus
Pregnancy or childbirth less than 6 months
Having diabetes, neurological disease, mental illness and debilitating chronic diseases such as kidney failure and heart pacemaker
Presence of drugs that affect urination
History of surgical or drug treatment of SUI
History of abdominal and inguinal hernia
Having a history of any surgery in the abdomen and pelvis (due to adhesions in the area and impact on the bladder)
Presence of constipation
History of seizures
Age
From 35 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
To use the random number table, the researcher first determines the direction of reading the numbers in the table (up, down, left or right). The researcher will consider the numbers 00-24 for the biofeedback group, the numbers 25-49 for the rTMS group, and the numbers 50-74 for the PFMT group. Then the researcher puts her hand on one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the type of intervention or control group in sealed envelopes that are coded. Coding is done by one of the colleagues of the project. The evaluator is blind to the grouping of the participants and the participants are blind to the type of interventions of the opposite group. According to Pan et al.'s study in 2020 for the sham group, the subjects received the same number of stimuli whose parameters are the same as the active group. However, the coil is rotated 90 degrees and only 1 wing will be in contact with the edge on the scalp, producing the same sound. Patients will not be familiar with the difference between rTMS-Sham and active rTMS in acoustic and tactile aspects.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Basij Blvd, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-03-18, 1401/12/27
Ethics committee reference number
IR.SEMUMS.REC.1401.336
Health conditions studied
1
Description of health condition studied
Urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Evaluation of urinary incontinence and vaginal symptoms
Timepoint
Before and after the intervention and one month after the last treatment session
Method of measurement
International Consultation on Incontinence Questionnaire Vaginal Symptoms Module questionnaire
2
Description
The volume of urine loss
Timepoint
Before and after the intervention and one month after the last treatment session
Method of measurement
One hour pad test
Secondary outcomes
1
Description
Bladder displacement amount
Timepoint
Before and after the intervention and one month after the last treatment session
Method of measurement
Ultrasonography
2
Description
Strength and endurance of pelvic floor muscles
Timepoint
Before and after the intervention and one month after the last treatment session
Method of measurement
Perineometer
3
Description
Strength and endurance of pelvic floor muscles
Timepoint
Before and after the intervention and one month after the last treatment session
Method of measurement
Manual assessment with the Oxford scale
4
Description
Strength and endurance of pelvic floor muscles
Timepoint
Before and after the intervention and one month after the last treatment session
Method of measurement
Biofeedback
Intervention groups
1
Description
Control group: This group receives only routine exercises to strengthen the pelvic floor muscles, each session is 30 minutes and is divided into three parts: 1) Sustained contractions: Patients complete pelvic muscle contraction for 6-10 seconds each time, then start the next contraction after 10 seconds rest, 8-10 repetitions per set, 1-2 sets per session. 2)Phasic contractions: Patients complete pelvic muscle contraction for 2-5 seconds each time, then rest, rest time is twice the contraction time, 10 repetitions per set, 1-3 sets per session. 3) Guided training: Patients are asked to simulate activities such as coughing, sneezing while contracting the pelvic floor muscles. Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks.
Category
Rehabilitation
2
Description
First intervention group: Pelvic floor muscle strengthening exercises with biofeedback : The treatment program includes 9 sessions of combined pelvic floor rehabilitation, that is, the combination of electromyographic biofeedback and progressive exercises of the pelvic floor muscles, will be used as a therapeutic exercise program. Biofeedback takes 15 minutes. A special vaginal probe of Leukoplast combination, which is the same for all patients, will be used for electromyographic biofeedback applications. Each probe will be unique to the patient. The patient will be given the necessary training to train the pelvic floor muscles alone and using vaginal cones in treatment sessions. According to the Kegel treatment protocol, 300 contractions are performed daily. Contraction of the pelvic floor by maintaining the vaginal cone while standing, lying down, sitting and going up and down the stairs as well as running will be done gradually at home with daily progress. Each patient's in-person treatment session will take 45 minutes to one hour. The treatment sessions will be performed 3 times a week for a total period of 3 weeks.
Category
Treatment - Devices
3
Description
Second intervention group: Repetitive Transcranial Magnetic Stimulation (rTMS) : All participants use the same rTMS device, which has a figure-of-eight coil with the handle facing the sensorimotor cortex on one side. The physiotherapist chooses the pelvic floor muscle as the reference muscle for applying rTMS, and rTMS is applied to the Supplementary Motor Area (SMA) which corresponds to the pelvic floor muscles. Patients are positioned in the supine position and inhibitory rTMS is used for this group of patients on the SMA for 20 minutes each time. LF-rTMS is a inhibitory protocol consisting of 1 pulse per second applied continuously (2000 pulses in total). Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Maryam Miri Torbaghan
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
maryammiritorbaghan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Miri Torbaghan
Street address
Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 915 933 8502
Email
maryammiritorbaghan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Miri Torbaghan
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
maryammiritorbaghan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
aminfar83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Miri Torbaghan
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
maryammiritorbaghan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD